Rectal Cancer, Recurrent
Conditions
Brief summary
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)
Interventions
patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation
Sponsors
Study design
Intervention model description
carbon ion therapy
Eligibility
Inclusion criteria
* 1\) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis, * 2\) received a radical operation for their primary tumor and regional lymph nodes, * 3\) received chemo-radiation or radiation in pelvic before CIRT, * 4\) received re-irradiation by CIRT after their pelvic radiotherapy.
Exclusion criteria
* 1\) received more than once prior radiotherapy in the same treatment field, * 2\) time to the last radiotherapy was \<1 year, * 3\) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (\<5 mm).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local control | Local control at 3 years after CIRT | local control rate of the lesion treated by CIRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years after CIRT or patient died, measured erery 3 months after CIRT | survival rate after CIRT |
| progression free survival | 3 years after CIRT or patient died, measured erery 3 months after CIRT | progression free survival rate after CIRT |
Countries
China